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Protocolized vs Discretionary Use of Opioids in Acute Pain

Information source: Montefiore Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Hydromorphone (Drug); IV opioid (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Montefiore Medical Center

Official(s) and/or principal investigator(s):
Andrew K Chang, MD, Principal Investigator, Affiliation: Montefiore Medical Center


We are testing whether patients who received protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patients wants more) will have better pain relief and no more adverse events than patients receiving discretionary care, in which the patients receives whatever IV opioid the treating physician wants to give, in whatever dose.

Clinical Details

Official title: Protocolized vs Discretionary Use of Opioids in Acute Pain

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Difference in proportion who answer "no" to the question, "Do you want more pain medication?" at 60 minutes.

Secondary outcome:

Difference in proportion of patients who answer "no" to the question, "Do you want more pain medication?" at 15 minutes

Changes in pain intensity from baseline to other pain assessment times (5, 15, 30, 45 and 60 minutes).

Incidence of adverse events


Minimum age: 21 Years. Maximum age: 64 Years. Gender(s): Both.


Inclusion Criteria: 1. Age 21 to 64 years. 2. Pain with onset within 7 days. 3. ED attending physician's judgment that patient's pain warrants use of intravenous opioids. 4. Normal mental status. Exclusion Criteria: 1. Prior use of methadone. 2. Use of other opioids, tramadol, or heroin in the past seven days. 3. Prior adverse reaction to morphine, hydromorphone, or other opioids. 4. Chronic pain syndrome. 5. Alcohol intoxication. 6. Systolic BP < 90 mm Hg. 7. Use of MAO inhibitors in past 30 days. 8. Weight less than 100 pounds. 9. Baseline room air oxygen saturation less than 95%. 10. C02 measurement greater than 46: In accordance with a number of similar studies that we have performed, four subsets of patients will have their CO2 measured using a handheld capnometer prior to enrollment in the study. If the CO2 measurement is greater than 46, then the patient will be excluded from the study. The 4 subsets are as follows: 1. All patients who have a history of COPD 2. All patients who have a history of sleep apnea 3. All patients who report a history of asthma together with greater than a 20 pack-year smoking history 4. All patients reporting less than a 20 pack-year smoking history who are having an asthma exacerbation

Locations and Contacts

Montefiore Medical Center Emergency Department, Bronx, New York 10467, United States
Additional Information

Starting date: October 2008
Last updated: July 19, 2011

Page last updated: August 23, 2015

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